Job title: GRA Global AdPromo Excellence Lead
- Location: Morristown, NJ - Cambridge, MA
About the jobA hybrid role combining support for global promotional material regulatory review (30%) with transversal excellence activities (70%). The position supports innovation, and operational efficiency across the GRA Advertising and Promotion (GRA AdPromo) organization while maintaining hands-on review expertise to ensure strategic initiatives remain grounded in operational realities.
Main Responsibilities:Global AdPromo Regulatory Review (~30%)- Work closely with the assigned global business units (commercial and medical) in the development of promotional / non-promotional materials, their review and prior approval. This also includes the review of internal and external documents issued by communication when related to products/diseases.
- Act as an advisor for the team regarding the review of promotional activities on global level and/or for the local affiliates;
- Review the regulatory aspects (as indicated in the Sanofi Global internet rules) of internet websites and social media (global).
- Define the minimal quality standard and processes to be applied worldwide. Support the set up of guidelines / Quality documents on topics related to regulatory requirements around promotional aspects to ensure appropriate communication to the relevant stakeholders;
- Advise teams on evolving regulatory requirements, industry trends, enforcement actions and complaints related to pharmaceutical advertising and promotion
Excellence Support Activities (~70%)Innovation & Transformation Support- Represent GRA AdPromo in transformation programs and cross-functional initiatives
- Support the evaluation and testing of digital tools and Gen AI use cases under guidance from the Excellence Head
- Help compile data and observations for system and process reviews
Stakeholder Coordination- Support coordination activities with transversal partners and regional teams
- Assist in preparing materials and communications for stakeholder meetings and updates
- Advocate for the AdPromo team's strategic value and priorities
Operational Excellence Support- Assist with data collection and documentation for gap analyses of regulatory processes
- Support maintenance of KPI reporting and dashboards by gathering and organizing relevant data
- Help document best practices, process updates, and SOP revisions under senior guidance
Training & Capability Building Support - Assist in the preparation process documentation for both transversal and regulatory
- Help maintain and update global training materials
- Conduct upskilling sessions with (regional) regulatory teams on digital initiatives
Governance & Ways of Working Support - Provide administrative and coordination support for GRA AdPromo Governance activities
- Assist in team engagement activities such as town halls and workshops
About youEducation- BA/BS degree in Pharmaceutical Sciences, Life Sciences, or related discipline required (other degrees considered with relevant experience)
Experience- 2+ years of experience in the biopharmaceutical industry performing regulatory affairs advertising and promotion review
Required Skills- Good understanding of global codes and standards including ability to review against the EFPIA and IFPMA standards
- Interpret complex clinical data (eg, CSRs, medical publications)
- Possesses sufficient scientific and clinical knowledge to understand disease states, mechanisms of action, clinical trial design, and statistical concepts relevant to the products being reviewed
- Use data and local SmPC to inform compliant messaging
- Understand review standards for branded, disease awareness, and medical congress content
Preferred Technical & Soft Skills- Experience supporting transversal and/or digital transformation initiatives like Gen AI, Modular Content, Core Claims, and or other MLR programs.
- Familiarity with regulatory technology systems such as Veeva and basic familiarity with digital tools and platforms (e.g., Microsoft Office, SharePoint)
- Eagerness to learn and grow within regulatory affairs and excellence functions
- Strong attention to detail and commitment to quality in all tasks
- Foundational understanding of pharmaceutical regulatory concepts (or willingness to develop this quickly)
- Good organizational and coordination skills
- Clear and professional written and verbal communication
- Collaborative mindset with the ability to work effectively within a team
- Adaptable and proactive in a fast-paced, evolving environment
Language- English (fluent required); additional languages beneficial
The salary range for this position is:
$122,250.00 - $176,583.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
